# FDA 483 - Eli Lilly Kinsale Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/eli-lilly-kinsale-ltd/81eaf3f1-68e9-40c2-bac9-011380761a51

> FDA 483 for Eli Lilly Kinsale Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Eli Lilly Kinsale Ltd.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Eli Lilly Kinsale Limited, a drug substance manufacturer in Kinsale, County Cork, Ireland, was cited for three observations during an FDA inspection. The firm demonstrated inadequate controls to prevent microbial contamination, had insufficient data to support product quality after bioburden excursions, and used a clarity testing method that did not meet European Pharmacopeia requirements. These issues indicate significant concerns regarding manufacturing process control, data integrity, and quality control testing.

## Related Documents

- [483 - 2018-03-16](https://www.globalkeysolutions.net/records/483/eli-lilly-kinsale-ltd/57ad931f-35e2-41dd-a9b8-31c2d27e745c)

## Related Officers

- [Biologist](https://www.globalkeysolutions.net/people/milos-dokmanovic/b6c79c1d-754a-46ab-977b-adc90cedcac2)
- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)
- [Laura Fenton](https://www.globalkeysolutions.net/people/laura-fenton/c0f85ce6-3580-4506-a1e3-4f75c52ccbae)

Company: https://www.globalkeysolutions.net/companies/eli-lilly-kinsale-ltd/1b83e59e-9251-41db-beec-42a9e7018ed4

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321